EpilepsyPhase 1NCT03116321

Bioequivalence of Two Different Sources of Eslicarbazepine Acetate

A Phase 1 study testing Eslicarbazepine acetate (ESL) in people with Epilepsy, run by Bial - Portela C S.A..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Epilepsy
What is being tested?: Eslicarbazepine acetate (ESL)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: 3 Dec 2016to 5 Jan 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects, 18 to 55 years of age (inclusive) at screening.
Body mass index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
Body weight not less than 50 kg.
Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Non smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).
Females, if:

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Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
OR
Of childbearing potential, the following conditions are to be met: Negative pregnancy test. If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.
Not lactating. Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study.
Examples of reliable methods of contraception include non hormonal intrauterine device and barrier methods combined with an additional contraceptive method.
In this study the concomitant use of hormonal contraceptives is NOT allowed. Other methods, if considered by the investigator as reliable, will be accepted (after discussion with sponsor medical monitor).
Males must agree to use an accepted method of contraception with a pregnant partner or partner of childbearing potential (barrier methods combined with an additional contraceptive method, true abstinence or vasectomy) throughout the study and refrain from donating sperm throughout the study.
Written consent given for participation in the study before any study-specific screening procedure is performed.

Who cannot join

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females. One unit (10 g alcohol) is equal to beer [330 mL], wine [200 mL], or distilled spirits [25 mL] per day.
Regular exposure to substances of abuse or a history of alcoholism within 1 year prior to the first dose of IMP.
Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator. In this study the concomitant use of hormonal contraceptives is NOT allowed.
Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin), whichever is the longer, before administration of IMP in this study, at the discretion of the investigator.
Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.

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A major illness during the 3 months before commencement of the screening period.
History of relevant hypersensitivity or allergy to any drug (including known hypersensitivity to the IMP, its excipients or to other carboxamide derivatives (e.g., carbamazepine, oxcarbazepine).
History of bronchial asthma or any other bronchospastic disease.
History of convulsions.
History of porphyria.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome. The IMP is contraindicated in second or third degree atrioventricular block.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP or received any blood or blood products.
Diagnosis of hypotension made during the screening period. Supine systolic blood pressure should be at least 90/140 mmHg and diastolic BP 50/90 mmHg.
Diagnosis of hypertension made during the screening period or current uncontrolled of hypertension.
Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
Positive testing for human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
Positive urine screen for drugs of abuse. In case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the investigator.
Positive pregnancy test.
Males or females who plan to procreate during the study, or not willing to practice reliable forms of male or female contraception during the study and males who refuse to refrain from donating sperm throughout the study.
Clinically relevant abnormalities in the coagulation tests.
Clinically diagnosed peptic ulceration within the past 5 years.
History of bleeding disorders.
Vegetarian or any abnormal diet (for whatever reason).
Difficulty in swallowing.
Immunization using a live organism vaccine within 4 weeks before the first dosing of IMP.
Any specific investigational product safety concern.
Vulnerable subjects, e.g., persons in detention.

About this study

Official title: A Single Center, Single Dose, Open Label, Laboratory Blind, Randomized, Three Period, Six Sequence, Crossover Study to Determine the Bioequivalence of Two Different Sources of Eslicarbazepine Acetate (800 mg) and to Assess the Dose Equivalence of Two Different Dose Strengths of Eslicarbazepine Acetate (200 and 800 mg) in Healthy Subjects

The purpose of this study is to determine whether the test product, eslicarbazepine acetate 800 mg tablets (test 1, To be marketed (TBM) Treatment A), and the reference product, eslicarbazepine acetate 800 mg tablets (current Active pharmaceutical ingredient (API) source - Marketed formulation (MF)) (Reference, Treatment C), are bioequivalent and to demonstrate dose equivalence between eslicarbazepine acetate 4 x 200 mg tablets (test 2, TBM Treatment B) and eslicarbazepine acetate 800 mg tablet (Reference).

Read the detailed description

The study will comprise:

Screening period of maximum 21 days before the first administration of the investigational medicinal product (IMP);
Three treatment periods (each of which will include a profile period of 72 hours) separated by a wash out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP, and
A post study visit within 1 and 2 weeks of completion of the last treatment period of the study or within 72 hours of termination or withdrawal.

Subjects will be assigned randomly to treatment sequence according to randomization schedule, before the first administration of IMP.

Subjects will be admitted to the study center on Day -1 and will be allowed to leave 24 hours after dosing. Subjects have to return for the subsequent blood sample collections up to 72 hours after dosing.

Conditions: Epilepsy
Being tested: Eslicarbazepine acetate (ESL)
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eslicarbazepine acetate (ESL)Drug
Also called Zebinix®, Aptiom®, Exalief®, BIA 2-093
Oral Tablet of 800 mg and 200 mg of ESL

Study groups in NCT03116321
Study group	Role	What they receive
Test 1 - TBM (Treatment A - 1 × 800 mg tablet)	Experimental	single oral dose of 800 mg (1 × 800 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral. Receives: Drug: Eslicarbazepine acetate (ESL)
Test 2 - TBM (Treatment B - 2 × 200 mg tablet)	Experimental	single oral dose of 800 mg (4 × 200 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral. Receives: Drug: Eslicarbazepine acetate (ESL)
Reference Product - MF (Treatment C - 1 × 800 mg tablet)	Active comparator	single oral dose of 800 mg (1 × 800 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral. Receives: Drug: Eslicarbazepine acetate (ESL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed plasma concentration (Cmax)
Primary Pharmacokinetic Parameters
Measured: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Area under the plasma concentration versus time curve from time zero to t, where t is the time of the last quantifiable concentration (AUC(0-t))
Primary Pharmacokinetic Parameters
Measured: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Area under the plasma concentration versus time curve with extrapolation to infinity (AUC(0-t))
Primary Pharmacokinetic Parameters
Measured: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose

Secondary outcomes (1)

Time to reach maximum observed plasma concentration (tmax)
Secondary Pharmacokinetic Parameters
Measured: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 20165 Jan 2017

First posted17 Apr 2017
Study start3 Dec 2016
Primary completion5 Jan 2017
Study completion5 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EpilepsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03116321
Sponsor's protocol ID: BIA-2093-131
Status last verified: Apr 2017
First submitted: 12 Apr 2017
Last updated: 17 Apr 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Single Dose, Open Label, Laboratory Blind, Randomized, Three Period, Six Sequence, Crossover Study to Determine the Bioequivalence of Two Different Sources of Eslicarbazepine Acetate (800 mg) and to Assess the Dose Equivalence of Two Different Dose Strengths of Eslicarbazepine Acetate (200 and 800 mg) in Healthy Subjects
ClinicalTrials.gov ID: NCT03116321
Acronym / sponsor ID: BIA-2093-131
Conditions: Epilepsy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: 3 Dec 2016 (actual)
Primary completion: 5 Jan 2017 (actual)
Study completion: 5 Jan 2017 (actual)
First posted: 17 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will comprise:

Screening period of maximum 21 days before the first administration of the investigational medicinal product (IMP);
Three treatment periods (each of which will include a profile period of 72 hours) separated by a wash out period of 7 calendar days (minimum number of days based on half-life of the analyte) to 14 calendar days (maximum number of days based on logistical arrangements) between consecutive administrations of the IMP, and
A post study visit within 1 and 2 weeks of completion of the last treatment period of the study or within 72 hours of termination or withdrawal.

Subjects will be assigned randomly to treatment sequence according to randomization schedule, before the first administration of IMP.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Test 1 - TBM (Treatment A - 1 × 800 mg tablet)	Experimental	Drug: Eslicarbazepine acetate (ESL)single oral dose of 800 mg (1 × 800 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral.
Test 2 - TBM (Treatment B - 2 × 200 mg tablet)	Experimental	Drug: Eslicarbazepine acetate (ESL)single oral dose of 800 mg (4 × 200 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral.
Reference Product - MF (Treatment C - 1 × 800 mg tablet)	Active comparator	Drug: Eslicarbazepine acetate (ESL)single oral dose of 800 mg (1 × 800 mg tablet) of Eslicarbazepine acetate (ESL) as tablets, on each of three separate occasions, under fasting conditions. Route of administration:Oral.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Healthy male and female subjects, 18 to 55 years of age (inclusive) at screening.
Body mass index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
Body weight not less than 50 kg.
Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Non smokers or mild to moderate smokers (≤ 10 cigarettes or pipes per day).

Key exclusion criteria (28 listed)

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females. One unit (10 g alcohol) is equal to beer [330 mL], wine [200 mL], or distilled spirits [25 mL] per day.
Regular exposure to substances of abuse or a history of alcoholism within 1 year prior to the first dose of IMP.
Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator. In this study the concomitant use of hormonal contraceptives is NOT allowed.
Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin), whichever is the longer, before administration of IMP in this study, at the discretion of the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eslicarbazepine acetate (ESL)Also: Zebinix®, Aptiom®, Exalief®, BIA 2-093Oral Tablet of 800 mg and 200 mg of ESL	Drug	Reference Product - MF (Treatment C - 1 × 800 mg tablet), Test 1 - TBM (Treatment A - 1 × 800 mg tablet), Test 2 - TBM (Treatment B - 2 × 200 mg tablet)

Primary outcome

Maximum observed plasma concentration (Cmax)
Time frame: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary Pharmacokinetic Parameters
Area under the plasma concentration versus time curve from time zero to t, where t is the time of the last quantifiable concentration (AUC(0-t))
Time frame: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary Pharmacokinetic Parameters
Area under the plasma concentration versus time curve with extrapolation to infinity (AUC(0-t))
Time frame: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose
Primary Pharmacokinetic Parameters

1 secondary outcome

Time to reach maximum observed plasma concentration (tmax)
Time frame: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
Individual participant dataSharing planned: Undecided

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eslicarbazepine acetate (ESL) in people with Epilepsy, run by Bial - Portela C S.A..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed plasma concentration (Cmax) (time frame: pre dose (0 hours) and at 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03116321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.